LivaNova's Latest VNS Therapy System for Epilepsy Wins FDA Nod

LivaNova PLC announced it received U.S. Food and Drug Administration (FDA) approvals for its latest Vagus Nerve Stimulation Therapy (“VNS Therapy”) System, which consists of the SenTiva implantable generator and the next-generation VNS Therapy Programming System for the treatment of patients with drug-resistant epilepsy. SenTiva is the smallest and lightest responsive therapy for epilepsy. The new VNS Therapy Programming System features a wireless wand and new user interface on a small tablet. Together, the components offer patients with drug-resistant epilepsy a physician-directed customizable therapy with smart technology and proven results to reduce the number of seizures, lessen the duration of seizures and enable a faster recovery.

“We created SenTiva and the accompanying VNS Therapy Programming System based on feedback received from patients and physicians to ensure ease of use, better patient care and cost effectiveness,” said Jason Richey, LivaNova’s president of North America and general manager of the neuromodulation business franchise. “In addition, SenTiva’s compact size allows for a more comfortable experience for pediatric patients, which is beneficial now that VNS Therapy is the first and only system that is FDA approved for drug-resistant epilepsy in children as young as four years of age.”

SenTiva is the first epilepsy device of its size to include detect-and-respond mode, designed to prevent seizures before they start and automatically deliver extra therapy to stop them if they do. SenTiva also collects and logs events commonly associated with seizures, including a patient’s body position and heart rate variations.

The VNS Therapy Programming System is compatible not only with SenTiva, but with all LivaNova legacy VNS Therapy generators, allowing physicians to use the system with numerous patients. When combined with SenTiva’s technology, the new system provides several advanced options and personalized features, including:

Scheduled programming—Physicians can safely program multiple therapeutic steps during one office visit; the generator will then gradually and automatically increase therapy without the need for the patient to return to the physician. Scheduled programming can be very helpful, since many patients with epilepsy are not able to drive. This feature may also allow the patient to achieve a therapeutic range sooner.

Day and night programming—Physicians have unrivaled flexibility to customize therapy when their patients need it at specific times, day or night.

“Since every patient suffering from seizures is different, we need more treatment options. SenTiva and the VNS Therapy Programming System will provide that additional flexibility and customization for our patients,” said Dr. James Wheless, Professor and Chief of Pediatric Neurology of Le Bonheur Children’s Hospital in Memphis, Tenn. “SenTiva is especially ideal for our pediatric patients. With VNS Therapy’s recently expanded age range, many more children living with drug-resistant seizures will have the opportunity for treatment beyond medication. Studies show that earlier use of VNS Therapy is proven to offer better long-term outcomes for children at a critical time in their development.”1,2,3